# K051370: Sterile Saline for Device Care, Sterile Water for Device Care, Models 2F7121, 2F8014

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Aug 12, 2005 after 78 days
- Product code: JOL (Catheter And Tip, Suction)
- Device class: 2
- Regulation: 21 CFR 880.6740
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Baxter Sterile Saline for Catheter Care: named in the summary without a submission number
- (no number) Welcon Sterile Water for Device Irrigation: named in the summary without a submission number

## Indications for use
Baxter Sterile Water for Device Care and Sterile Saline for Device Care are indicated for irrigation and flushing of medical devices. Baxter Sterile Water for Device Care and Sterile Saline for Device Care are not indicated for intravascular injection.

Source page: https://510kreport.com/device/K051370
Methodology: https://510kreport.com/methodology